roux-en-y gastric bypass for bmi 27-32 type 2 diabetes versus best medical treatment

Conditions: Type II Diabetes in Subjects BMI 27 to 32

Summary: investigators aim to show that roux-en-y gastric bypass (rygb) is superior to best medical treatment in reaching well-defined treatment end points in asian subjects of bmi 27-32 with type 2 diabetes (dm2). investigators also hope to show that successful rygb will reduce resource utilization in the near term with similar projected reduction over the medium to long term.

40 subjects with dm2 will be recruited, randomised into two arms. the surgical arm will be subjected to rygb. the medical arm will be treated maximally utilising the best means available and following internationally available protocol/guidelines. the study population will be subjected to a set of tests which is over and above the standard tests for similar groups of patients undergoing standard care (details below). some test samples will be bio-banked. treatment end points and follow up protocol will be the same for each treatment arm. the international diabetic federation (idf) in 2011 recommended that bariatric surgery should be considered an alternative treatment option for those asian dm2 subjects with bmi of 27 or above. data for the effectiveness of bariatric surgery for those dm subjects with lower bmi is not as well established as those with higher bmi. there is scant good quality data, especially from asian subjects. as their treatment is totally funded by the research project, subjects on the non surgical treatment arm will benefit from the more intense management of their disease with no restriction due to cost. the surgical arm will also be fully funded by the research project. they will be exposed to the standard risks associated with this type of surgery. subjects in both arms will have to provide more blood and other samples than usual and has to follow visits protocol as close as possible. rygb is a major surgical procedure, with significant potential complications; during the process of surgery and afterwards, both short and long term. procedure related mortality is about 0.3%. major complications that may require surgical intervention includes: anastomotic leakage about 3-4%, bleeding 3%, infection 3%, venous thrombo-embolism 1%. some of these complications will require prolong hospitalisation. after surgery, loose stool, dumping syndrome, anastomotic ulcers can occur in less than 3%.life long dietary supplement will be required. longer term post surgical complications include intestinal obstruction due to adhesions or internal hernia, about 2%, further surgery may be needed. this risk is lifelong. nutritional deficiencies, especially if not compliant with regular supplement intake, may occur. drug allergies can occur; from simple rash to life threatening anaphylactic reaction. blood taking can cause bruising, pain at the puncture site and sometimes fainting.

Eligibility criteria:
inclusion criteria: 1. established diagnosis of dm2 = or \< 10 years 2. age 21-65 3. bmi 27-32. 4. hba1c ≥ 8%, on maximum treatment from primary care physician 5. at least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or ≤class i nephropathy, retinopathy. exclusion criteria: 1. subjects who had previous bariatric surgery or extensive upper abdominal surgery 2. pregnant subjects. 3. nephropathy requiring dialysis 4. subjects who are not fit for general anaesthesia. 5. subjects who are unsuitable for rygb for whatever reason, medical/surgical/psychological. 6. subjects who are unwilling or possibly unable to participate in the follow up process. 7. subjects who are reluctant to be randomised into the two study groups. 8. subjects who suffers from unstable psychiatric illness 9. subjects who are active substance abusers 10. glutamic acid decarboxylase antibody positive. 11. fasting c-peptide \< 300 pmol/l

Keywords: diabetes surgical treatment medical treatment